MAMMOMAT B.brilliant (11372950)
FDA 510(k) K253678 · Siemens Medical Solutions USA, Inc.
510(k) numberK253678
Submission
- Device name
- MAMMOMAT B.brilliant (11372950)
- Applicant
- Siemens Medical Solutions USA, Inc.
Malvern, PA, US - Received
- November 21, 2025
- Decision date
- June 18, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was MAMMOMAT B.brilliant (11372950) cleared by the FDA?
MAMMOMAT B.brilliant (11372950) (K253678) received a 510(k) decision of Substantially Equivalent on June 18, 2026, 209 days after the submission was received.
What is the product code of K253678?
The FDA product code is MUE – Full Field Digital, System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1715.